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JOURNAL ONKOLOGIE – STUDIE
BlastCrisis

European CML Blast Crisis Register

Rekrutierend

NCT-Nummer:
NCT03869502

Studienbeginn:
Oktober 2018

Letztes Update:
10.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Jena

Collaborator:
-

Studienleiter

Annamaria Brioli, PhD MD
Principal Investigator
Univerity of Jena

Kontakt

Studienlocations
(3 von 9)

Alle anzeigen

Studien-Informationen

Detailed Description:

Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast

crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic

myeloid leukemia (CML) will evolve into a blast phase at some point during the course of

their disease. Furthermore, despite the advances made in CML treatment, outcome of patients

with blast crises are still dismal. Due to the rarity of this condition clinical trials are

challenging, and collaboration between researchers both at national and international level

is needed to collect a meaningful number of data.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age >18 years

- Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:

- Blasts 20% or more of peripheral blood white cells or bone marrow cells or

- Extramedullary blast proliferation or

- Large foci or clusters of blasts in bone marrow biopsy

Exclusion Criteria:

- Lack of informed consent

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - through study completion in 2024):
how many patients survive after a blast crisis event



Secondary outcome:

1. Rate of hematologic response to treatment (Time Frame - through study completion in 2024):
how many patients have a hematologic response to the local standard Treatment after a blast crisis event

2. Rate of molecular response to treatment (Time Frame - through study completion in 2024):
how many patients have a molecular response to the local standard Treatment after a blast crisis event

3. Rate of blast crises in Europe in the era of TKI treatment (Time Frame - through study completion in 2024):
how many patients have blast crisis events compared to all treated CML-patients in the trial centers

Quelle: ClinicalTrials.gov


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